Mechanical Leaflet Guides for Controlled Valve Prosthesis Crimping
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Solution Overview
Problem
Existing heart valve prostheses face challenges in maintaining a low profile for transcatheter delivery while preventing damage to leaflets during crimping, which can lead to irregular folding and increased delivery system size.
Innovation Solution
A leaflet folding accessory with flexible guide fingers, made of pliable materials like silicone or PTFE, holds leaflets in a predetermined state during crimping, using semi-spherical tips to minimize damage and ensure a controlled folding pattern, allowing for a smaller delivery profile.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Volume of moving object
If the heart valve prosthesis is radially compressed into a crimped configuration for delivery, then the delivery profile is reduced and can be delivered through vasculature, but the leaflets may be damaged or fold irregularly during crimping
Solution Approach 1:
The guide fingers are positioned and configured to hold the leaflets in a predetermined folded state before crimping begins. This preliminary positioning ensures that when radial compression is applied, the leaflets are already in the correct configuration and protected from damage during the crimping process.
Solution Approach 2:
The guide fingers act as an intermediary mechanism between the crimping force and the leaflets. They transmit and distribute the compression force uniformly across the leaflets, preventing localized stress concentrations that could cause damage while maintaining the desired folded configuration.
2Manufacturing precision
If the leaflets are held in a predetermined state during crimping using guide fingers, then the folding pattern is controlled and consistent, but the device complexity increases
Solution Approach 1:
The guide fingers are constructed from flexible materials that allow them to conform to the leaflet surfaces and maintain contact during crimping. This flexibility enables the guide fingers to adapt to slight variations in leaflet geometry while maintaining consistent folding control, without requiring complex rigid mechanical structures.
Solution Approach 2:
The guide finger structure is divided into multiple segments or sections, each capable of independent movement or adjustment. This segmentation allows the guide fingers to accommodate the three-dimensional folding of multiple leaflets while maintaining a relatively simple overall structure that can be integrated into the delivery system.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The accessory prevents leaflet damage and ensures a consistent, compact crimped configuration, enhancing packing efficiency and reducing the required delivery system size.
Implementation Method 1
The leaflet folding accessory includes a plurality of guide fingers, each guide finger having a first end and a second end. Each guide finger is formed of a pliable polymer material... the second end of each guide finger is configured to contact the prosthetic valve component and hold the at least one leaflet in a closed state against an inner shaft
Data Source
AI summary
An assembly including a transcatheter valve prosthesis and a leaflet folding accessory configured for use when compressing the transcatheter valve prosthesis into the crimped configuration. The transcatheter valve prosthesis includes a stent and a prosthetic valve component including at least one leaflet disposed within and secured to the stent. The transcatheter valve prosthesis has a crimped configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve. The leaflet folding accessory includes a plurality of guide fingers. Each guide finger is configured to contact the prosthetic valve component and hold the at least one leaflet in a predetermined configuration when the transcatheter valve prosthesis is compressed into the crimped configuration.